Bard® Urethral Catheterization Tray with Plastic Catheter 772416Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00801741030420), received between May 25, 2017 and Feb 18, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PLASTIC CATHETERS CAUSED INJURY TO THE PATIENT. NO MEDICAL INTERVENTION WAS REPORTED. PER FOLLOW UP ON 01FEB2022, NURSE STATED THAT THE PATIENT EXPERIENCED BLEEDING AND ABRASIONS TO THE URINARY TRACT AS THE CATHETER WAS NOT BEING ABLE TO INSERT CORRECTLY DUE TO BEING MET WITH RESISTANCE. STATED THAT THE PATIENT WAS MONITORED AND GIVEN PAIN MEDS AS NEEDED BUT NO OTHER MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: Abrasion; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13561977 ↗
• MalfunctionNov 15, 2018Use of Device Problem; Use of Device Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CATHETER WITH AN ADDITIONAL "RING" ON THE END INSERTED. UPON REMOVAL OF THE CATHETER, THE PATIENT ALLEGEDLY EXPERIENCED TRAUMA AND SELF-LIMITED BLEEDING. IT WAS ADVISED TO MONITOR THE PATIENT FOR ANY FURTHER COMPLICATIONS. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Patient Problem/Medical Problem

  MAUDE report 8075323 ↗
• MalfunctionAug 5, 2018Gel Leak; Gel Leak

  IT WAS REPORTED THAT THE POVIDONE-IODINE SWABS LEAKED WITHIN THE CATHETER KIT. THE LEAK WAS REPORTEDLY NOTICED BY STAFF UPON OPENING THE CATHETER KIT. REASON FOR REPORT: INVESTIGATION RESULTS. (B)(4). INITIAL ASR REPORT SUBMITTED: QUARTER 1/2018. CORRESPONDING EXEMPTION NUMBER: E1997042.

  Patient problems: No Patient Involvement

  MAUDE report 7750741 ↗
• MalfunctionMay 25, 2017Component Missing

  IT WAS REPORTED THAT THE CATHETER WAS MISSING FROM THE TRAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6593080 ↗